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The state drug administration issued five medical devices regulations
2017-01-19
Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, on the basis of demonstration, solicit opinions from all sides, and revising the "measures for the administration of medical device registration, registration measures for the management of in vitro diagnostic reagent, the medical instrument instruction manual and the regulations on the label, the medical instrument the measures for the supervision and administration of production, the measures for the supervision and administration of medical devices management five rules. Five rules adopted on June 27, administration approval, will come into force as of October 1, 2014 in medical equipment industry will usher in a more normative market order

Five rules according to the risk degree of medical devices (high and low, set scientific examination and approval and filing system, detailed rules on the product registration (record), and enterprise production and business license requirements, procedures, time limit, the main duties and responsibilities of enterprises, the detailed specifications and requirements for labels, means and measures to strengthen the regulatory supervision and inspection, strict liability, for medical device registration (record), and the production and business operation provides a clear guidance, to strengthen the supervision of medical devices and governance provides a strong support.

Five regulations come on stage is of great significance for improving the medical device regulatory system, standardize the order of medical apparatus and instruments market, promote the healthy development of the medical equipment industry, guarantee the medical equipment is safe and effective, safeguard human health and life safety. Next step, the administration will actively carry out five rules and interpretation and relevant publicity and training work, to lay a good foundation for the enforcement of the regulations.



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